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Blood Glucose and Body Fat Regulatory Effect of Peanut Skin Extract

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537912
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
You-Cheng Shen, Chung Shan Medical University

Brief Summary:
The regulatory effects of the peanut skin extract (Sugarlock®) on body fat and blood glucose was demonstrated in a double-blind, placebo-controlled study. .

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Sugarlock® Dietary Supplement: Placebo Not Applicable

Detailed Description:
Peanut skins, a by-product of peanut processing industry, is usually discarded as a waste in despite of the high content of phenolic compounds. Polyphenol extract from peanut skins has been demonstrated to inhibit α-amylase activity in vitro. Hence, the aim of this study was to evaluate the regulatory effects of the peanut skin extract on blood glucose and body fat by a double-blind, placebo-controlled, clinical study. Subjects with simple obesity (body mass index [BMI] ≥ 27 or body fat ≥ 30%) ingested 4 Sugarlock® (n = 16) capsules or placebo (n = 14) a day for a total of 6 weeks. Anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every three weeks. Also, 5 subjects were randomly selected for MRI scans to examine the distribution and thickness of abdominal fat layers before and after the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effects of Peanut Skin Extract on Blood Glucose Regulation and Body Fat Reduction
Study Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Active Comparator: Sugarlock®
Subjects ingested 2 capsules Sugarlock® (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
Dietary Supplement: Sugarlock®
Subjects ingested 2 capsules (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
Other Name: peanut skin

Placebo Comparator: Placebo
Subjects ingested 2 capsules placebo (Control group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks.
Dietary Supplement: Placebo
Subjects ingested 2 capsules placebo in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.




Primary Outcome Measures :
  1. The changes of body fat of the subjects. [ Time Frame: 6 weeks ]
    values change of body fat (%) between before to after 6 weeks


Secondary Outcome Measures :
  1. The changes of fasting blood glucose (FBG) of the subjects [ Time Frame: 6 weeks ]
    values change of fasting blood glucose (FBG) between before to after 6 weeks



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults ages 20-70 years;
  • Body mass index (BMI) ≥ 27 or body fat ≥ 30;
  • No history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs;
  • No drugs consumption.

Exclusion Criteria:

  • BMI >35;
  • Alcoholic;
  • US-controlled diabetics;
  • Stoke in past one year;
  • High blood pressure;
  • Mental diseases or melancholia;
  • Pregency or breast-feeding a child.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537912


Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: You-Cheng Mr Shen, Ph.D. Chung Shan Medical University

Publications:
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Responsible Party: You-Cheng Shen, School of Health Diet and Industry Managment, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT02537912    
Other Study ID Numbers: CS13167
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Keywords provided by You-Cheng Shen, Chung Shan Medical University:
peanut skin
body fat
blood glucose
waistline
body weight